BPT to Improve Bodily Disturbances in Post-treatment Cancer Patients (KPTK)

January 8, 2020 updated by: University Hospital, Basel, Switzerland

A Clinical Trial of Group-based Body Psychotherapy (BPT) to Improve Bodily Disturbances in Post-treatment Cancer Patients in Combination With Randomized Controlled Smartphone-triggered Bodily Interventions

With this project investigators focus on the evaluation whether bodily disturbances in post-treatment cancer patients can be influenced positively by group BPT and if intermittent smartphone-triggered bodily interventions are effective.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Disturbances in bodily wellbeing represent one key aspect of psychosocial impairments related to cancer. Therefore, interventions to improve bodily wellbeing in post-treatment cancer patients are important.

Objectives: This project aims at two goals:

  1. Investigators want to evaluate whether bodily disturbances in post-treatment cancer patients can be influenced positively by group BPT (Non-randomized evaluation of a weekly group BPT using a waiting-period comparator).
  2. In addition the efficacy of intermittent smartphone-triggered bodily interventions is assessed with a nested RCT to evaluate short-term efficacy of smartphone-triggered bodily interventions.

Study design: The project follows the outline of a non-randomized evaluation of a weekly group BPT using a waiting-period comparator, with a nested randomized controlled trial (RCT) to evaluate the short-term efficacy of smartphone-triggered bodily interventions.

Study flow:

  • Participants will first undergo a waiting period (duration at least 6 weeks) followed by the group BPT (6 weekly sessions, 90 minutes each).
  • During the group BPT, either a smartphone-triggered bodily intervention or a smartphone-triggered control intervention will be provided at random (randomization on a daily basis) over a period of 5 consecutive weeks on 6 days per week. This will result in 15 smartphone-triggered bodily interventions and 15 smartphone-triggered control interventions, which each patient will undergo.

Measurement points: Patients will be surveyed at three points in time (initial consultation, pre- and post-intervention). Standardized questionnaires will be used to measure patients' body disturbances, body image, body mindfulness, physical complaints, quality of life, vitality, mental health, anxiety and depression and to explore the effects of BPT on bodily disturbances and body image in post-treatment cancer patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Department of Psychosomatics/ Division of Medicine; University Hospital of Basel
      • Winterthur, Switzerland, 8401
        • Department of Oncology and Hematology; Kantonsspital Winterthur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Having received curatively intended treatment for any malignant neoplasm; primary treatment (surgery, radiotherapy, chemotherapy) being completed >/= 3 months ago before study inclusion. Any other ongoing anti-tumor therapy is allowed (e.g., hormonal therapy, adjuvant immunotherapy)
  • existing bodily disturbances
  • No sign of progress or recurrence of malignancy at study inclusion according to treating physician
  • Score of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) Performance Score
  • Having an anticipated life expectancy of >/= 12 months, according to treating physician
  • age 18 years or older
  • Capacity to participate in group BPT sessions in Basel or Winterthur, 3 study assessments, and the smartphone-triggered interventions
  • Ability to provide informed consent

Exclusion Criteria:

  • Suffering from a severe current mental disorder
  • Risk of current suicidality, as indicated by a suicide item score >/= 2 in the BDI-II (Beck Depression Inventory), as this group BPT intervention is not appropriate to support suicidal patients in acute crises
  • Participation in any other clinical trial with a psychosocial intervention
  • Receiving any other current psychotherapeutic treatment with the exception of already established therapies
  • Inability to understand and speak German

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Group BPT

Six group BPT sessions (using a waiting-period comparator and pre-/post design)

A nested randomized controlled trial (RCT) is included to evaluate the short-term efficacy of smartphone-triggered bodily interventions compared with the smartphone triggered control intervention of audio-typed fairy tales.
Behavioral: BPT
BPT will consist of 6 weekly group sessions, based on a scientific approach, integrating body-oriented techniques to improve patients' awareness, perception, acceptance, and expression regarding their body.
Behavioral: Smartphone-triggered bodily interventions
Smartphone-triggered bodily interventions will consist of brief BPT exercises insuring the transfer from the group BPT sessions into patients' daily lives. Smartphone bodily interventions will be triggered by short audio-clips.
Behavioral: Smartphone triggered control intervention
The smartphone triggered control intervention will be selected fairy tales presented by audio-clips.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in bodily disturbances assessed by questionnaires
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
self-perception of change in appearance and displeasure with change or perceived change in appearance; assessed via Body Image Scale (BIS). BIS total score is calculated by adding the score obtained on each item, yielding a possible range from 0-30. Higher scores indicate a higher degree of body image dissatisfaction.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in bodily wellbeing
Time Frame: applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions
bodily wellbeing is assessed by Multidimensional Mood Questionnaire (MDMQ). 3 scales are calculated: "good-bad", and "awake-tired", "calm-nervous". Scores are calculated by adding the score obtained on each item, yielding a possible range from 4-20 in each scale. Higher values represent a better outcome.
applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions
Changes in mood
Time Frame: applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions
mood is assessed by Multidimensional Mood Questionnaire (MDMQ). 3 scales are calculated: "good-bad", and "awake-tired", "calm-nervous". Scores are calculated by adding the score obtained on each item, yielding a possible range from 4-20 in each scale. Higher values represent a better outcome.
applied twice on each training day of the smartphone-triggered interventions: first directly preceding, second directly following the smartphone-triggered interventions
Changes in body mindfulness
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
assessed by Body Mindfulness Questionnaire (BMQ). 2 scales are calculated: "Experiencing Body Awareness", and "Appreciating Body Awareness". Scores are calculated by adding the score obtained on each item, yielding a possible range from 7-42 in each scale. Higher values represent a better outcome.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in somatic symptoms
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
somatic symptoms are assessed by the EORTC QLQ-C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items). All scales and single-item measures range in scores from 0 to 100. A high score represents a high level of symptomatology. The following somatic symptom scales are calculated: fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea. The principle for scoring these scales is the same in all cases: 1.The average of the items that contribute to the scale is estimated; this is the raw score. 2. A linear transformation is used to standardise the raw score, so that scores range from 0 to 100.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in somatic symptom disorder-B criteria
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
somatic symptom disorder-B criteria are assessed by Somatic Symptom Disorder-B Criteria Scale (SSD-12). 1 total score and 3 subscores are calculated: "cognitive aspects", "affective aspects", and "behavioral aspects". Scores are calculated by adding the score obtained on each item. Range for subscales: 0-16; range for total score: 0-48; higher scores are representing greater severity.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in distress
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
distress is assessed by National Comprehensive Cancer Network Distress Thermometer (DT). A visual analogue scale ranging from 0=no distress to 10=extreme distress.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in anxiety
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
anxiety is assessed by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A). The anxiety-score is calculated by adding the score obtained on each item, range 0-21, with higher scores representing greater severity.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in depression
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Depression is assessed by the depression subscale of the Hospital Anxiety and Depression Scale (HADS-D). The depression-score is calculated by adding the score obtained on each item, range 0-21, with higher scores representing greater severity.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in vitality
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
vitality is assessed by the 36-Item Short Form Health Survey (SF-36) - scale vitality. Items in the scale are averaged together to create the vitality score. Range from 0 to 100, a higher score defining a more favorable health state.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in mental health
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
mental health is assessed by the 36-Item Short Form Health Survey (SF-36) - scale mental health. Items in the scale are averaged together to create the mental health score. Range from 0 to 100, a higher score defining a more favorable health state.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in quality of life
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
quality of life is assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 items (EORTC QLQ-C30). The following scales are computed: global health status/quality of life, physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. All scales range in scores from 0 to 100. A high score for a functional scale represents a high level of functioning, a high score for the global health status represents a high quality of life. The principle for scoring these scales is the same in all cases: 1.The average of the items that contribute to the scale is estimated; this is the raw score. 2. A linear transformation is used to standardise the raw score, so that scores range from 0 to 100.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
Changes in suicidal tendency
Time Frame: Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)
suicidal tendency is assessed by the Beck Depression Inventory (BDI-II), Item I: Suicidal tendency. Range from 0 to 3, a higher value representing a higher suicidal tendency.
Questionnaire at baseline and 6 weeks after baseline (=after the waiting period;pre-therapy) and 14 weeks after baseline (=post-therapy)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in bodily disturbances assessed by semistructured interview
Time Frame: qualitative assessment at baseline and 14 weeks after baseline (=post-therapy)
self-perception of change in appearance and displeasure with change or perceived change in appearance; assessed via semistructured interview
qualitative assessment at baseline and 14 weeks after baseline (=post-therapy)
Change in group cohesion
Time Frame: assessed 7, 8, 9, 10, 11 and 12 weeks after baseline directly after each group session
Group cohesion is assessed by the Group Climate Questionnaire - Short Form (GCQ-S). The questionnaire consists of a total score and 3 subscales (all ranges from 0 to 6): Scale 1: Engaged: This describes the positive working group atmosphere. Scale 2: Conflict: This reflects anger and tension in the group. Scale 3: Avoiding: This describes behaviors indicating avoidance of personal responsibility of group work by the members. Higher values represent a higher degree in engagement, conflict, or avoiding. Scales scores are determined by calculating the mean of the relevant items.
assessed 7, 8, 9, 10, 11 and 12 weeks after baseline directly after each group session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Rainer M Schaefert, Prof. Dr. MD, Department of Psychosomatics/ Division of Medicine
  • Principal Investigator: Astrid Grossert, MSc, Department of Psychosomatics/ Division of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 5, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-01115; me17Schaefert2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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